Long-term follow-up of pediatric MS patients starting treatment with injectable first-line agents: A multicentre, Italian, retrospective, observational study

Author:

Baroncini Damiano1ORCID,Zaffaroni Mauro1,Moiola Lucia2,Lorefice Lorena3,Fenu Giuseppe3,Iaffaldano Pietro4ORCID,Simone Marta5,Fanelli Fulvia6,Patti Francesco7,D’Amico Emanuele7,Capobianco Marco8,Bertolotto Antonio8,Gallo Paolo9,Margoni Monica9,Miante Silvia9,Milani Nicoletta10,Amato Maria Pia11,Righini Isabella11,Bellantonio Paolo12,Scandellari Cinzia13,Costantino Gianfranco14,Scarpini Elio15,Bergamaschi Roberto16,Mallucci Giulia16,Comi Giancarlo17,Ghezzi Angelo1

Affiliation:

1. Multiple Sclerosis Study Center, Gallarate Hospital, ASST Valle Olona, Via Eusebio Pastori 4, 21013 Gallarate, Italy

2. Department of Neurology, San Raffaele Hospital, Milan, Italy

3. Multiple Sclerosis Center, Binaghi Hospital, ATS Sardegna, Cagliari, Italy/Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy

4. Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy

5. Child and Adolescence Neuropsychiatry Unit, Department of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari Aldo Moro, Bari, Italy

6. Centro Sclerosi Multipla, Azienda Ospedaliera Sant Andrea, Università degli studi di Roma La Sapienza, Rome, Italy

7. Centro Sclerosi Multipla, Azienda Ospedaliera Sant Andrea, Università degli studi di Roma La Sapienza,Rome, Italy/Department of Medical and Surgical Science and Advanced Technologies, GF Ingrassia, Neurosciences Section, Multiple Sclerosis Center, University of Catania, Catania, Italy

8. Neurologia & CRESM (Centro Riferimento Regionale SM), AOU San Luigi, Orbassano, Italy

9. Multiple Sclerosis Centre, Department of Neurosciences DNS, University Hospital, University of Padua, Padua, Italy

10. Child Neuropsychiatry Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

11. Department NEUROFARBA, University of Florence, Florence, Italy

12. Multiple Sclerosis Center, IRCCS Neuromed, Isernia, Italy

13. UOSD Riabilitazione e Sclerosi Multipla, Villa Mazzacorati, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy

14. Simple Unit Multiple Sclerosis, University Hospital of Ospedali Riuniti, Foggia, Italy

15. Multiple Sclerosis Center “Dino Ferrari,” University of Milan IRCCS Fondazione Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy

16. Department of Neurology, Neurological Institute C. Mondino, Pavia, Italy

17. Department of Neurology, San Raffaele Hospital, Milan, Italy/Department of Neurology, Institute of Experimental Neurology, Division of Neuroscience, San Raffaele Hospital, Milan, Italy/

Abstract

Background: Few data are available on very long-term follow-up of pediatric multiple sclerosis (MS) patients treated with disease modifying treatments (DMTs). Objectives: To present a long-term follow-up of a cohort of Pediatric-MS patients starting injectable first-line agents. Methods: Data regarding treatments, annualized relapse rate (ARR), Expanded Disability Status Scale (EDSS) score, and serious adverse event were collected. Baseline characteristics were tested in multivariate analysis to identify predictors of disease evolution. Results: In total, 97 patients were followed for 12.5 ± 3.3 years. They started therapy at 13.9 ± 2.1 years, 88 with interferons and 9 with copaxone. During the whole follow-up, 82 patients changed therapy, switching to immunosuppressors/second-line treatment in 58% of cases. Compared to pre-treatment phase, the ARR was significantly reduced during the first treatment (from 3.2 ± 2.6 to 0.7 ± 1.5, p < 0.001), and it remained low during the whole follow-up (0.3 ± 0.2, p < 0.001). At last observation, 40% had disability worsening, but EDSS score remained <4 in 89%. One patient died at age of 23 years due to MS. One case of natalizumab-related progressive multifocal encephalopathy (PML) was recorded. Starting therapy before 12 years of age resulted in a better course of disease in multivariate analysis. Conclusion: Pediatric-MS patients benefited from interferons/copaxone, but the majority had to switch to more powerful drugs. Starting therapy before 12 years of age could lead to a more favorable outcome.

Publisher

SAGE Publications

Subject

Clinical Neurology,Neurology

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